NCT01687426已完成1 期
A Single-Center, Randomized, Double-Masked, Cross-Over Pilot Study Evaluating Safety and IOP Lowering Response of Brimonidine Tartrate Ophthalmic Solution Versus Vehicle in Subjects With Open Angle Glaucoma or Ocular Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- IOP
研究概览
简要总结
The purpose of this study is to determine the intraocular Pressure (IOP) lowering response and evaluate the safety of brimonidine tartrate 0.025% ophthalmic solution in adult subjects with open angle glaucoma or ocular hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 18 years of age at Visit 1 (Screening), of either sex and any race
- •Be willing and able to provide written informed consent prior to any study procedures being performed.
- •Be willing and able to follow all instructions and attend all study visits.
- •Be willing to discontinue use of disallowed medication
- •Have a documented diagnosis of ocular hypertension, open angle glaucoma or chronic angle closure glaucoma with a patent iridotomy.
排除标准
- •Have known sensitivity or poor tolerance to brimonidine or any other component of the study medications.
- •Have any form of glaucoma other than open-angle glaucoma, ocular hypertension or chronic angle closure glaucoma with patent iridotomy.
研究组 & 干预措施
Brimonidine Tartrate 0.025%
Active Comparator
干预措施: Brimonidine Tartrate 0.025% (Drug)
Brimonidine Tartrate 0.025%
Active Comparator
干预措施: Vehicle (Drug)
Vehicle
Placebo Comparator
干预措施: Brimonidine Tartrate 0.025% (Drug)
Vehicle
Placebo Comparator
干预措施: Vehicle (Drug)
结局指标
主要结局
IOP
时间窗: 14 days
次要结局
未报告次要终点
研究者
研究点 (1)
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